Innovative Strategies For Risk Reduction Following CABG
Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore, there is a need for new strategies to assist patients in meeting these goals.
Objective: To determine the amount of any additional benefit on risk factor reduction associated with the consumption of the "dietary portfolio" (a low fat diet with soy, nuts and viscous fibres), above that achieved with medical management in diabetic patients following cardiac surgery.
Description: 35 cardiac surgery patients with diabetes will be instructed on how to incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be assessed after 2 and 4 weeks of therapy.
Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus medication) should improve outcomes, reduce rates of re-hospitalization and improve quality of life in diabetic patients after heart surgery.
|Coronary Artery Disease Type II Diabetes Mellitus||Behavioral: Consumption of Dietary Portfolio||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?|
- Primary Outcome: Reduction of total and LDL cholesterol [ Time Frame: baseline to 4 weeks ]
- Improvement in endothelial function and EPC counts [ Time Frame: Baseline to 4 weeks ]
- Reduction in CRP [ Time Frame: baseline to 4 weeks ]
- Feasibility and tolerability [ Time Frame: Baseline to 4 Weeks ]
- Reduction in markers of inflammation ie TNF, IL-6 [ Time Frame: Baseline to 4 weeks ]
- Improved markers of glycemic control - fructosamine, HOMA [ Time Frame: baseline to 4 weeks ]
|Study Start Date:||February 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Behavioral: Consumption of Dietary Portfolio
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462436
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Mary Keith, PhD, RD||St. Michael's Hospital, Toronto|